Type of Product |
Medical Device |
TGA Recall Reference |
RC-2015-RN-00098-1 |
Product Name/Description |
Engstrom Carestation and Engstrom Pro Ventilators (that were provided with an accessory cart as part of the original order)
Serial Numbers: CBCN01062 through CBCQ01396
ARTG Number: 108308 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
6/02/2015 |
Responsible Entity |
|
Reason/Issue |
It has been identified that specific combinations of Engstrom ventilator casters and bases pose an increased likelihood of failures of the caster mounting hardware. A failure of the caster mounting hardware may result in the ventilator falling/tipping (overbalancing). A fall/tip of the Engstrom ventilator can result in serious injury to patients or clinical staff. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
GE is replacing all affected accessory carts. End users are advised that they can continue to use the cart until replaced, however the casters must be checked for signs of damage and loosening. This action has been closed-out on 03/08/2016. |
Contact Information |
1800 659 465 - GE National Call Centre |